FDA Restricts Use of Antibiotic Ketek®
WASHINGTON, DC — March 2, 2007 — Because the antibiotic Ketek® (telithromycin) has been linked to severe liver damage, it should no longer be used to treat bacterial sinusitis and bronchitis, according to the Food and Drug Administration (FDA). The agency points out that sinusitis and bronchitis are not life–threatening conditions and respond to other drugs. Ketek®’s manufacturer, Sanofi–Aventis, recently changed the drug’s label to delete these two former uses.
The FDA will still allow Ketek® to be prescribed for community–acquired pneumonia (bacterial pneumonia that is not acquired in hospitals or nursing homes). Unlike bronchitis and sinusitis, pneumonia can be a fatal disease. Even for pneumonia patients, however, an FDA panel has concluded that alternative medication should be tried before using Ketek®.
Patients with myasthenia gravis should not use Ketek® at all, according to a high alert or “black box” warning the FDA added to the Ketek® label and prescribing instructions. Myasthenia gravis is a chronic disease that causes fatigue and muscle weakness. Some patients with myasthenia gravis who took Ketek® suffered from respiratory failure or died.
The FDA also strengthened warnings about visual problems that could be experienced by Ketek® users and added that they could lose consciousness while taking the drug. Because of these potential difficulties, Ketek® users should limit their driving and try not to operate heavy machinery while undergoing treatment.
Ketek® Side Effects Include Liver Damage
Since Ketek® was approved in April 2004, the FDA has received at least 110 reports of injuries caused by the drug, including 23 cases of liver damage, 14 liver failures and four deaths (New York Times, June 29, 2006; December 16, 2006). A doctor who recruited patients for a study that allegedly led to Ketek®’s approval was later convicted of providing fake data. Three Congressmen have claimed that the FDA relied on biased foreign reports in their recommendation for Ketek®’s approval.
The FDA finally issued warnings about the connection between Ketek® and severe liver damage in January and June of 2006 (Public Health Advisory, January 20, 2006; FDA News, June 29, 2006). Then, in December of that year, two FDA advisory panels met and agreed that because of liver toxicity issues, Ketek® should not be used to treat sinusitis or bronchitis.
Your Ketek® Case
The FDA web site contains the latest prescribing instructions for Ketek® as well as an updated Patient Medication Guide. You will need Adobe Acrobat to open these files. If you do not already have this software, you may download a free copy from the Adobe Acrobat web site.
If you or a family member suffered liver damage or other injuries after taking Ketek®, please feel free to contact us at Brayton Purcell. We will evaluate your case free of charge, answer your questions, and explain your legal rights.
Each state has a deadline for filing legal claims once you have been injured. Therefore, we suggest that you contact us as soon as possible to get legal information if you have been injured by an unsafe drug.